奥希替尼治疗既往治疗过的、EGFR T790M突变阳性的晚期非小细胞肺癌中国患者的真实世界数据：一项回顾性研究
Real-World Data on Osimertinib in Chinese Patients with Pretreated, EGFR T790M Mutation Positive, Advanced Non-Small Cell Lung Cancer: A Retrospective Study.
作者信息
Peng Da, Shan Dongfeng, Dai Chengcheng, Li Jie, Wang Zifan, Huang Ziyi, Peng Rui, Zhao Peng, Ma Xuezhen
机构信息
Department of Oncology, Affiliated Qingdao Central Hospital, Qingdao University, Qingdao, Shandong, People's Republic of China.
The Affiliated Hospital of Qingdao University, Qingdao, Shandong, People's Republic of China.
出版信息
Cancer Manag Res. 2021 Feb 26;13:2033-2039. doi: 10.2147/CMAR.S287466. eCollection 2021.
PURPOSE
As a third-generation EGFR TKI has been taken orally, Osimertinib effectively inhibits mutant EGFR, including T790M EGFR resistance mutations. Here, we examined real-world efficacy and tolerability of Osimertinib among Chinese patients with advanced EGFR T790M-mutant NSCLC.
PATIENTS AND METHODS
A total of 106 advanced NSCLC patients who were taking Osimertinib following disease progression after EGFR-TKIs or other treatments were retrospectively recruited in this study. The PFS and OS after Osimertinib treatment were analyzed as the primary endpoints.
RESULTS
Osimertinib was used as a second line and ≥3rd line treatment in 22.6% and 77.4% of the patients, respectively. DCR and ORR were 93.4% and 57.5%, respectively. Median PFS was 12.4 12 (95% CI, 10.5-13.5) months. The PFS was 11 (8.0, 14.0) and 12 (10.3,13.7) months ( = 0.373), in patients with and without CNS metastasis, respectively. PFS in 2nd and ≥3rd line treatment was 11 (9.0, 13.0) and 12.4 12 (8.9, 15.1) months ( = 0.799), respectively. In patients with EGFR exon 19 deletion and exon 21 L858 mutation, the median PFS was 11 (9.2, 12.8) and 12 (9.2, 14.8) months, respectively ( = 0.833). Median PFS in the monotherapy group and combined anti-angiogenesis group was 11 (9.9,12.1) and 14 (11.2,16.8) months, respectively. Median OS after Osimertinib initiation was 27 (19.6, 34.4) months: 15 (6.9, 23.1) and 27 (22, 32) months in patients with and without CNS metastasis (p=0.027), 27 (20.3,33.7) months and (undefined) as second line or ≥3rd line of treatment ( = 0.421), respectively. In patients with exon 19 deletion, the median OS was not reached, and in patients with exon 21 L858 mutations, the median OS was 23 (19.1,29.9) months (p=0.027). Median OS in the monotherapy group was 27 (21.7,32.3) months, and in combined anti-angiogenesis group was not reached (p=0.68).
CONCLUSION
Osimertinib can effectively treat advanced NSCLC with T790M mutations independently of previous treatment lines.
目的
作为第三代口服表皮生长因子受体酪氨酸激酶抑制剂（EGFR TKI），奥希替尼可有效抑制突变型EGFR，包括T790M EGFR耐药突变。在此，我们研究了奥希替尼在中国晚期EGFR T790M突变非小细胞肺癌（NSCLC）患者中的真实疗效和耐受性。
患者与方法
本研究回顾性纳入了106例在表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKIs）或其他治疗后疾病进展后服用奥希替尼的晚期NSCLC患者。分析奥希替尼治疗后的无进展生存期（PFS）和总生存期（OS）作为主要终点。
结果
分别有22.6%和77.4%的患者将奥希替尼用作二线及三线以上治疗。疾病控制率（DCR）和客观缓解率（ORR）分别为93.4%和57.5%。中位PFS为12.4个月（95%置信区间，10.5 - 13.5个月）。有和无中枢神经系统转移的患者的PFS分别为11个月（8.0，14.0）和12个月（10.3，13.7）（P = 0.373）。二线及三线以上治疗的PFS分别为11个月（9.0，13.0）和12.4个月（8.9，15.1）（P = 0.799）。对于表皮生长因子受体第19外显子缺失和第21外显子L858突变的患者，中位PFS分别为11个月（9.2，12.8）和12个月（9.2，14.8）（P = 0.833）。单药治疗组和联合抗血管生成组的中位PFS分别为11个月（9.9，12.1）和14个月（11.2，16.8）。奥希替尼开始治疗后的中位OS为27个月（19.6，34.4）：有和无中枢神经系统转移的患者分别为15个月（6.9，23.1）和27个月（22，32）（P = 0.027），二线或三线以上治疗分别为27个月（20.3，33.7）和（未定义）（P = 0.421）。对于第19外显子缺失的患者，中位OS未达到，对于第21外显子L858突变的患者，中位OS为23个月（19.1，29.9）（P = 0.027）。单药治疗组的中位OS为27个月（21.7，32.3），联合抗血管生成组未达到（P = 0.68）。
结论
奥希替尼可有效治疗具有T790M突变的晚期NSCLC，与先前的治疗线数无关。
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